Quality Assurance Manager Europe

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Utrecht Netherlands.

This international organisation has built up a well- known, reliable brand. They offer infusion therapy with a complete set of products varying from IV pumps to the accompanying software. They are recently merged with a subsidiary of another global market player within Medical Devices. From there, they are creating a new business which focuses on innovation and high-quality.

ROLE DESCRIPTION

In your role as European QA manager, you will be the organisation's representative on a local level. Your main responsibility is to interact with various local and European authorities. You will take on the part of regulatory and quality assurance procedures, which should be discussed with various stakeholders. This will involve topics as post market inspection, safety regulations, and activities on location. Furthermore, as a manager you will mentor your team members and provide them with correct knowledge of RA and QA procedures in Class l classification. Next to that, you have the responsibility to distribute this knowledge among external stakeholders. This role is at least for half a year with possible extension to 2 years.

RESPONSIBILITIES

* Complete and control documentation which should be presented to European authorities
* Creating awareness for regulation and legislation among internal and external stakeholders
* Asses and improve the Quality Management System in relation to latest market releases and/ changes
* Performing Risk analysis and make this documentation understandable for other involved departments
* Identify needs and demands for training and create methods to address these issues
* Develop and apply strategies that generate regulatory commitment, meetings with authorities and address field changes
* Interact and establish relationships with manufacturing site, authorities and internal parties

REQUIREMENTS

* Master degree in Pharmacy
* Minimal 6 years of experience with QA role in Medical Devices organisation
* Minimal 2 years of experience with Quality Assurance/ Regulatory Affairs of Class l products classifications
* Experience with European competent Authorities or agencies
* Extraordinary communication skills both written and verbal
* Fluency in English
* Evidence of analytical and problem solving skills
* Knowledge of Risk management procedures
* Affection with infusion therapy
* Excellent knowledge of European regulations and the differences across member states, and understanding of the EFTA members
* Evidence of leadership and mentoring skills

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.